Givosiran is used to treat acute hepatic porphyria in adults.

Acute hepatic porphyria is a rare genetic disorder that can cause life-threatening attacks on the nervous system. Symptoms include severe stomach pain, nausea and vomiting, numbness, weakness, or mental status changes. This disorder is more common in women during their child-bearing years.

Givosiran may also be used for purposes not listed in this medication guide.

You will need frequent blood tests and your next dose may be delayed based on the results.

Follow all directions and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Givosiran is injected under the skin, usually once per month.

A healthcare provider will give you this injection.

You will need frequent blood tests to check your liver function before and during treatment with givosiran. Your next dose may be delayed based on the results.

Your kidney function may also need to be checked.

Givosiran doses are based on weight. Your dose needs may change if you gain or lose weight.

Usual Adult Dose for Porphyria:

2.5 mg/kg subcutaneously once a month

Comments:
-Dosing is based on actual body weight.
-Administration should be performed by a healthcare professional.

Use: For the treatment of acute hepatic porphyria (AHP).

You should not use givosiran if you are allergic to it.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether givosiran will harm an unborn baby. However, having acute hepatic porphyria during pregnancy may cause serious medical problems in both mother and baby. The benefit of treating this disorder may outweigh any risks to the baby.

It may not be safe to breastfeed while using givosiran. Ask your doctor about any risk.

Get the missed injection as soon as possible, and then go back to your regular injection schedule. Do not use two doses at one time.

Since givosiran is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Your injections may be delayed or permanently discontinued if you have certain side effects.

Common side effects of givosiran may include:

• nausea; or

• pain, itching, rash, discoloration, or swelling where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect givosiran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.